The Effect of Biomechanical Scapular Mobilization With Movement and Motor Learning (BSMWM)

April 29, 2022 updated by: Moataz Abdelaal, Pharos University in Alexandria

The Effect of Biomechanical Scapular Mobilization With Movement and Motor Learning in Shoulder Impingement Patients

the study about new mobilization technique used in shoulder impingement syndrome patient to increase the range of motion of elevation, decrease the pain, and increasing the function level, this technique is based on normal mechanics that occur inside the joint during certain movement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is about a new technique of mobilization based on normal biomechanics that occurs during the movements of a joint. For example, shoulder abduction or elevation needs the scapula to move upward rotation with posterior tilt and external rotation. Moreover, needs glenohumeral (GH) joint glide inferior and posterior these movements occur normally to permit us to elevate our shoulder without any restriction and the full range of motion(ROM). so in the patients with shoulder problems and have difficulties reaching full ROM of elevation the investigators applied mobilization of scapula toward upward rotation with external rotation and posterior tilt and by using mobilization belt applied posterior and inferior glide to GH joint. However, mobilization techniques have a short-term effect to enhance this effect, the investigators adding a motor learning approach to achieve a long-term effect and prevent recurrent .the investigators applied this technique 3 times per week for 3 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Pharos University in Alexandria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

clinical diagnosis: shoulder impingement syndrome.

  1. History of shoulder pain when they elevated their arm.
  2. Limited range of motion due to the pain.
  3. Pain localized at the painful point at proximal anterolateral shoulder region or medical diagnosis of shoulder impingement syndrome with at least 2 positive impingement tests including Neer, Hawkins, or Jobe test.

Exclusion Criteria:

  • Fibromyalgia.
  • Fracture, dislocation, or subluxation of the shoulder.
  • history of trauma.
  • shoulder surgery.
  • numbness or tingling in the upper limb.
  • Corticosteroids injection within 1 year.
  • systemic illness.
  • ligamentous laxity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: group A (controlled group)
received passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM) exercises, strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). This treatment was repeated three times per weeks with 24 hours rest for 3 weeks.
Other: biomechanical scapular mobilization with movement and motor learning
the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula.
ACTIVE_COMPARATOR: group B(Study group)
All patients in group B received biomechanical scapular mobilization with movement and motor learning and traditional methods.
Other: biomechanical scapular mobilization with movement and motor learning
the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 3 weeks
1. Visual Analogue Scale: was used to evaluate the intensity of pain, which The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually, 10 centimetres in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10 centimetres).
3 weeks
Universal Goniometer
Time Frame: 3 weeks
Universal goniometer: was used to measure the available range of motion at a joint. where used to measure an available range of motion of abduction and flexion of the shoulder joint.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pharos University in Alexandria

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Moataz A. Mohamed, (B.Sc.P.T.), Pharos University in Alexandria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PUA 201901013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. Book
    Information comments: Neumann, D. D. (2010). kinesology of musculoskeletal system. In Mosby, Inc., an affiliate of Elsevier Inc. The book described normal biomechanics of the shoulder during the elevation.
  2. Book
    Information comments: the posterior glid and inferior glid of GH joint is increasing the range of motion and decreasing the pain
  3. Clinical Study Report
    Information comments: the effect of mobilization in increasing range of motion and decreasing of pain

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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